Comparison of Two Temperatures to Treat Insomnia

Primary Insomnia Clinical Trial

Official title:

A Multi-center Prospective, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790256
• Other study ID #: Cereve CIP-003
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: May 5, 2015
• Start date: January 2013
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: Cereve, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia patients. The current study is a two dose study to determine the optimal temperature for the Cereve Sleep System. Primary outcome measures include EEG sleep measured sleep latency and sleep efficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

Age >/= 22

Diagnosis of insomnia that meets criteria for DSM IV diagnosis of primary insomnia and International Classification of Sleep Disorders (ICSD)general insomnia criteria and RDC insomnia disorder criteria

Subjects must remain alcohol-free and avoid drugs that could affect sleep during the study.

>14 on the Insomnia Severity Index

Sleep -Wake diaries demonstrate sleep efficiency <85% on at least 50% of nights

Exclusion Criteria:

Neuropsychiatric disorders that may independently affect sleep, brain function or cognition, such as current major syndromal psychiatric disorders, including DSM-IV mood, anxiety, psychotic, and substance use disorders.

Specific exclusionary diagnoses include major depressive disorder, dysthymic disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, generalized anxiety disorder, any psychotic disorder, and any current substance use disorder.

Unstable medical conditions Raynaud's Disease

Irregular sleep schedules including shift workers;

A latency to persistent sleep < 15 on either the sleep disorder screening night or the baseline PSG sleep night;

A sleep efficiency > 85% on either the sleep disorder screening night or the baseline PSG sleep night;

An AHI (apnea hypopnea index) > 10 and/or a periodic limb movement arousal index (PLMAI) > 15 from SN1

Body Mass Index >34

Use of medications known to affect sleep or wake function

Consumption of more than one alcoholic drink per day, or more than 7 drinks per week prior to study entry.

Caffeinated beverages > 4/day or the equivalent of more than 4 cups of coffee Unable to read or understand English

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Cereve Sleep System at 30 degrees C

• Cereve Sleep System at 14-16 degrees C

Locations

Country	Name	City	State
United States	Alan Lankford	Atlanta	Georgia
United States	Russell Rosenberg	Atlanta	Georgia
United States	David Mayleben	Crestview Hills	Kentucky
United States	Leon Rosenthal	Dallas	Texas
United States	Paul Wylie	Little Rock	Arkansas
United States	Timothy Grant	Miami	Florida
United States	David Seiden	Pembroke Pines	Florida
United States	Mark Muehlbach	St. Louis	Missouri
United States	Neil Feldman	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cereve, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnographically determined sleep latency as changed from baseline measures	Polysomnographically determined sleep parameters	1-2 weeks	No
Primary	Poloysomnographically determined sleep efficiency as changed from baseline measures		1-2 weeks	No